ISO 22803:2004

Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file

ISO 22803:2004 gives the requirements for a technical file on the evaluation of the chemical, physical, mechanical, biological and clinical aspects and behaviour of membrane materials, whether resorbable, partially resorbable or non-resorbable, which are used

a) for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality,

b) in contact with teeth and/or dental implants,

c) for prevention of epithelial migration in periodontal surgery,

d) for the augmentation of bone prior to the planned insertion of dental implants,

e) and/or for augmentation of bone for stabilization of dental prostheses.

This International Standard is not applicable to materials whose primary intended use is to deliver a medicinal product, autografts and allografts, or materials intended to act through pharmacological, immunological or metabolic means.

To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ